Identity
- Trade Name
- Closed-end ratchet wrench EUDAMED
- Device Name
- Closed-end ratchet wrench EUDAMED
- Model / Reference
- INS-1029 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391529582425 EUDAMED
- Basic UDI-DI
- B-05391529582425 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Closed-end ratchet wrench by OrthoXel DAC — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05391529582425 | Class I | Active |
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Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (1)
- EUDAMED 723a8ee1-a3c7-4649-8d95-e969d015aea2 61 fields · synced Jul 10, 2026